PREMARIN

What it is

PREMARIN is a medicine containing conjugated estrogens. The medicine is available in tablet strengths of 0.3 mg and 0.625 mg. PREMARIN tablets are film-coated, with the 0.3 mg tablets dark green and marked "0.3", and the 0.625 mg tablets maroon and marked "0.625".

Approved indications

— Moderate to severe vasomotor symptoms associated with estrogen deficiency in natural and surgical menopause (sweating, hot flushes). — Atrophic vaginitis. — Prevention of postmenopausal osteoporosis in select patients. — Hypoestrogenic states, including female hypogonadism, primary ovarian failure or female castration.

Dosing overview

For female hypogonadism, the dose is 2.5 to 7.5 mg daily, in divided doses for 20 days, followed by a rest period of 10 days duration. For female castration and primary ovarian failure, the dose is 0.3 mg to 1.25 mg daily. Continuous daily administration of PREMARIN is generally recommended.

Key safety warnings

Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. Estrogens with or without progestogens should not be used for the prevention of cardiovascular disease or dementia. The estrogen-alone substudy of the Women's Health Initiative (WHI) study reported increased risks of stroke and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with conjugated estrogens (0.625 mg) relative to placebo. The estrogen plus progestogen substudy of the WHI reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with conjugated estrogens combined with medroxyprogesterone acetate (0.625 mg/2.5 mg) relative to placebo. The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with conjugated estrogens alone and during 4 years of treatment with conjugated estrogens/medroxyprogesterone acetate relative to placebo. Because of these risks, estrogens with or without progestogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Contraindications

PREMARIN is contraindicated in patients with known or suspected pregnancy; known, suspected or history of breast cancer; known or suspected estrogen-dependent neoplasia (such as endometrial cancer, endometrial hyperplasia); undiagnosed abnormal genital bleeding; active or history of confirmed venous thromboembolism (such as deep venous thrombosis, pulmonary embolism); active or history of arterial thromboembolic disease (such as stroke, myocardial infarction); severe uncontrolled hypertension; other undiagnosed breast pathology; active or chronic liver dysfunction or disease; known thrombophilic disorders (such as protein C, protein S or antithrombin deficiency); or known or suspected hypersensitivity to conjugated estrogens or any excipients in the tablet.

PBS listing

This information is not provided in the source documents.

Regulatory history

PREMARIN was first approved on 30 March 1995. The 0.3 mg and 0.625 mg tablet formulations were first listed on the ARTG on 28 May 2012. In November 2017, the PBAC recommended PREMARIN for the treatment of moderate to severe vasomotor symptoms associated with menopause in women with a uterus.